Safety of SBRT With Anti-PD1 and Anti-IL-8 for the Treatment of Multiple Metastases in Advanced Solid Tumors and Melanoma

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Yana Najjar
Study ID
NCT04572451
Phase
PHASE1
Status
Recruiting
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Conditions

  • Antineoplastic Agents
  • Antineoplastic Agents, Immunological
  • Immune Checkpoint Inhibitors
  • Melanoma
  • Molecular Mechanisms of Pharmacological Action
  • Neoplasms
  • Neoplasms by Histologic Type
  • Neoplasms by Site
  • Nivolumab
  • Unresectable Solid Tumors

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • nivolumab — DRUG
    Nivolumab (BMS-936558-01), 480 mg intravenous (every 4 weeks) Treatment must be within 7 days of the last dose of radiation.
  • BMS-986253 — DRUG
    BMS-986253 (Anti-IL-8), 2,400 mg intravenous (every 2 weeks) Treatment must be within 7 days of the last dose of radiation.
  • Stereotactic Body Radiotherapy (SBRT) — RADIATION
    Stereotactic Body Radiotherapy (SBRT) (varying doses) SBRT: Initial Dose fractionation of 3 or 5 fractions of radiation as determined by the location of the metastases to be irradiated, to at least 1 but no more than 4 metastatic lesions. There will be a minimum of 40 hours between treatments for an individual metastasis. SBRT must be completed within a 14-day window, separate from the screening phase. Treatment with nivolumab and BMS-986253 must be within 7 days of the last dose of radiation.

Study Details

Nivolumab (and other agents affecting the anti-programmed death-1 \[anti-PD-1\] pathway) have demonstrated anti-tumor activity in multiple tumor types. Combinations of immune-oncology (IO) agents with complimentary mechanisms as well as radiation represent a promising strategy to improve response rates to immunotherapy and overcome resistance. In this phase I/Ib study, radiation will be used in combination with IO agents nivolumab and anti-IL-8 (BMS-986253) to assess toxicity by organ system and then assess the preliminary efficacy of the treatment regimen. In Part 1, the study will determine the safe doses of radiation by organ site in conjunction with nivolumab and BMS-986253. In Part 2, the treatment regimen will be investigated in melanoma, prioritizing acral melanoma, to describe the response rate to treatment as well as other clinical and safety outcomes. The study will also provide the opportunity to evaluate changes in the tumor microenvironment induced by the treatment.

Key Dates

Start date
Nov 29, 2021
Status verified
Jul 2025
Primary completion
May 17, 2024
Completion
May 31, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Nivolumab (Anti-PD-1) + BMS-986253 (Anti-IL-8) + SBRT
    480 mg intravenous nivolumab (BMS-936558-01) every 4 weeks + 2,400 mg intravenous BMS-986253 (Anti-IL-8) every 2 weeks + Stereotactic Body Radiotherapy (SBRT)

Primary Outcome Measure

Rate of Dose Limiting Toxicities (DLT) [ Time Frame: Up to 8 weeks after start of immunotherapeutic treatment ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of Chicago Medical CenterChicagoIllinois60637
Robyn Hseu, RN
[email protected]
Steven Chmura, MD (PRINCIPAL_INVESTIGATOR)
UPMC Hillman Cancer CenterPittsburghPennsylvania15232
Danielle L Bednarz, BSN
[email protected]
412-623-1191
Amy L Rose, BSN
[email protected]
412-647-8587
Yana Najjar, MD, FACP (PRINCIPAL_INVESTIGATOR)

Find similar trials in Chicago, IL

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
University of Chicago Medical Center· Chicago, ILUPMC Hillman Cancer Center· Pittsburgh, PA

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